A wide range of parameters can adversely impact the quality of manufactured products within a facility. Such parameters can include, but are not limited to, the presence of viable microbiological organisms, the presence of particulates and other environmental conditions within the facility, such as humidity, pressure, temperature, water quality (e.g., pH, conductivity, total organic content (TOC), endotoxin, coliform, and metals), and the respective amounts of different materials involved in the manufacture of the end product(s).
Conventional software packages, such as Microsoft Excel spreadsheet and Access database programs, lack the processing and reporting power, and thus they do not pass governmental regulatory requirements for pharmaceutical, biotechnology, and medical device manufacturers. For example, these programs do not provide any audit trail or electronic signature capabilities as required by the FDA. See e.g., 21 CFR Part 11.
In conventional laboratory information management systems (LIMS), the chemistry of water samples is entered into a predetermined fixed database.
One system, called the Environmental Monitoring Software System (by Compliance Software Solutions Corp. of Vernon Hills, Illinois, the assignee of the present invention), provides a cost effective and efficient means to manually enter into a computer database program the presence of viable microbiological organisms, the presence of particulates and other environmental conditions within the facility, such as humidity, pressure, temperature, water quality (e.g., pH, conductivity, total organic content (TOC), endotoxin, coliform, and metals), and the respective amounts of different materials involved in the manufacture of the end product(s). Thus, this system provides a means to access and document facility operations and trend data to ensure that the environmental control systems of a facility are operating as intended. This system is particularly useful for pharmaceutical, biotechnology, and medical device manufacturers, who must comply with strict quality control requirements of governmental bodies. This system meets the requirements of 21 CFR Part 11.
While this system is quite useful and successful, all of the data must be entered manually into the database of the system. Also this system does not provide the user with the capability of configurable reports, such as configuring: certain data records to include in the reports, displayed fields, sort and grouping of data records, formatting of data (e.g., tables and graphs). Further, this system allows each authorized user to access all system functions, which may be undesirable from a security standpoint.